Monograph Title Monograph Section Scientific Liaison · environmental quality and control ... syrups, systems, tablets, general considerations, product quality tests, general, dosage

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Compendial Deferrals for USP 34-NF 29, Second Supplement

Monograph Title Monograph Section ScientificLiaison

<81> ANTIBIOTICS--MICROBIAL ASSAYS PF 36(5)Pg. 1239

Introduction, APPARATUS, MEDIA AND DILUENTS,UNITS AND REFERENCE STANDARDS, PREPARATIONOF THE STANDARD, PREPARATION OF THE SAMPLE,ORGANISMS AND INOCULUM, PROCEDURE,CALCULATION, INTRODUCTION AND GENERALINFORMATION, CYLINDER-PLATE METHOD,TURBIDIMETRIC METHOD, MEDIA AND SOLUTIONS,CALCULATIONS, APPENDIX 1. FORMULAS FORMANUAL CALCULATIONS OF REGRESSION ANDSAMPLE CONCENTRATION, APPENDIX 2. PROCEDUREFOR CHECKING FOR OUTLIERS; REJECTION OFOUTLYING OR ABERRANT MEASUREMENTS

Ahalya Wise

<111> DESIGN ANDANALYSIS OF BIOLOGICALASSAYS PF 36(4) Pg. 952

STEPS PRECEDING THE CALCULATION OF POTENCY,EXPERIMENTAL ERROR AND TESTS OF ASSAYVALIDITY

Tina Morris

<232> ELEMENTALIMPURITIES--LIMITS PF 36(1)Pg. 197

Title, INTRODUCTION, LIMITS OF ELEMENTALIMPURITIES, OPTIONS FOR DESCRIBING LIMITS OFELEMENTAL IMPURITIES, ANALYTICAL PROCEDURES

KahkashanZaidi

<233> ELEMENTALIMPURITIES - PROCEDURESPF 36(1) Pg. 201

Title, INTRODUCTION, ALTERNATIVE PROCEDUREVALIDATION REQUIREMENTS, VALIDATION OF LIMITPROCEDURES, VALIDATION OF QUANTITATIVEPROCEDURES, REFEREE PROCEDURES 1 AND 2,CALCULATIONS AND REPORTING

KahkashanZaidi

<761> NUCLEAR MAGNETICRESONANCE PF 36(2) Pg. 462

Title, Introduction, APPARATUS, THE SPECTRUM,GENERAL METHOD, INTRODUCTION, QUALIFICATIONOF NMR INSTRUMENTS, QUALITATIVE ANDQUANTITATIVE NMR ANALYSIS, PROCEDUREVALIDATION, GLOSSARY

KahkashanZaidi

<797> PHARMACEUTICALCOMPOUNDING--STERILEPREPARATIONS PF 36(3) Pg.714

DEFINITIONS, IMMEDIATE-USE CSPS, HAZARDOUSDRUGS AS CSPS, RADIOPHARMACEUTICALS AS CSPS,ENVIRONMENTAL QUALITY AND CONTROL

Shawn Becker

<1032> DEVELOPMENT ANDDESIGN OF BIOASSAYS PF36(4) Pg. 956

Title, 1. INTRODUCTION, 2. BIOASSAY FITNESS FORUSE, 3. BIOASSAY FUNDAMENTALS, 4. STATISTICALASPECTS OF BIOASSAY FUNDAMENTALS, 5. STAGESIN THE BIOASSAY PROCESS

Tina Morris

<1033> VALIDATION OFBIOLOGICAL ASSAYS PF36(4) Pg. 986

Title, 1. INTRODUCTION, 2. FUNDAMENTALS OFBIOASSAY VALIDATION, 3. A BIOASSAY VALIDATIONEXAMPLE, 4. LITERATURE

Tina Morris

<1034> ANALYSIS OFBIOLOGICAL ASSAYS PF36(4) Pg. 1005

Title, 1. INTRODUCTION, 2. OVERVIEW OF ANALYSISOF BIOASSAY DATA, 3. ANALYSIS MODELS, 4.CONFIDENCE INTERVALS, 5. LITERATURE,APPENDIX&#x2013;GLOSSARY, GLOSSARY

Tina Morris

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REFERENCES

<1050> VIRAL SAFETYEVALUATION OFBIOTECHNOLOGYPRODUCTS DERIVED FROMCELL LINES OF HUMAN ORANIMAL ORIGIN PF 36(3) Pg.726

I. INTRODUCTION, II. POTENTIAL SOURCES OFVIRUSVIRALCONTAMINATION, III. CELL LINEQUALIFICATION: TESTING FOR VIRUSES, IV. TESTINGFOR VIRUSES IN UNPROCESSED BULK, V. RATIONALEAND ACTION PLAN FOR VIRAL CLEARANCE STUDIESAND VIRUS TESTS ON PURIFIED BULK, VI.EVALUATION AND CHARACTERIZATION OF VIRALCLEARANCE PROCEDURESVI. GOALS, PRINCIPLES,DESIGN, AND EVALUATION OF VIRAL CLEARANCESTUDIES, VII. SUMMARY, GLOSSARY, APPENDIX I.GLOSSARY, APPENDIX 1, APPENDIX 2, APPENDIX 4.VIRUS ABBREVIATIONS, APPENDIX 3, APPENDIX 5

Tina Morris

<1113> MICROBIALIDENTIFICATION PF 35(1) Pg.167

Title, INTRODUCTION, MICROBIAL ISOLATION,PRELIMINARY SCREENING OF MICROBIAL ISOLATES,MICROBIAL IDENTIFICATION BY PHENOTYPICMETHODS, MICROBIAL IDENTIFICATION BYGENOTYPIC METHODS, VERIFICATION OF MICROBIALIDENTIFICATION METHODS

RadhakrishnaTirumalai

<1119> NEAR-INFRAREDSPECTROSCOPY PF 36(2) Pg.532

INSTRUMENTATION Horacio Pappa

<1151> PHARMACEUTICALDOSAGE FORMS PF 35(5) Pg.1260

Introduction, BIOAVAILABILITY, TERMINOLOGY,AEROSOLS, BOLUSES, CAPSULES, CONCENTRATEFOR DIP, CREAMS, ELIXIRS, EMULSIONS, EXTRACTSAND FLUIDEXTRACTS, GELS, IMPLANTS (PELLETS),INFUSIONS, INTRAMAMMARY, INHALATIONS,INJECTIONS, IRRIGATIONS, LOTIONS, LOZENGES,OINTMENTS, OPHTHALMIC PREPARATIONS, PASTES,POWDERS, PREMIXES, SOLUTIONS, SUPPOSITORIES,SUSPENSIONS, SYRUPS, SYSTEMS, TABLETS,GENERAL CONSIDERATIONS, PRODUCT QUALITYTESTS, GENERAL, DOSAGE FORMS, DRY POWDERINHALERS, EMULSIONS (CREAMS AND LOTIONS),FEED ADDITIVES, FOAMS, MEDICAL GASES(INHALATION MATERIALS), GRANULES, MEDICATEDGUMS, INSERTS, LIQUIDS, LOTIONS (SEE EMULSIONS),TRANSDERMAL SYSTEMS (PATCHES), PILLS,PLASTERS, MEDICATED SOAPS AND SHAMPOOS,SPRAYS (NASAL, PULMONARY, OR SOLUTIONS FORNEBULIZATION), TAPES, GLOSSARY

William Brown

<1761> APPLICATIONS OFNUCLEAR MAGNETICRESONANCESPECTROSCOPY PF 36(2) Pg.539

Title, PRINCIPLES OF NMR, NMR SPECTROMETERS,RELAXATION, TIP ANGLE, RELAXATION DELAY,RESOLUTION, POSTACQUISITION DATA PROCESSING,GENERAL PROCEDURE FOR STRUCTUREIDENTIFICATION, QUANTITATIVE APPLICATIONS,SOLID-STATE NMR, LOW-FIELD NMR

KahkashanZaidi

<2232> ELEMENTAL

Title, INTRODUCTION, LIMITS OF ELEMENTALCONTAMINANTS, OPTIONS FOR COMPLIANCE WITHTHE LIMITS OF ELEMENTAL CONTAMINANTS,

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CONTAMINANTS INDIETARY SUPPLEMENTS PF36(1) Pg. 258

ANALYTICAL PROCEDURES FOR TOTAL ELEMENTALCONTAMINANTS, ANALYTICAL PROCEDURE FORINORGANIC ARSENIC, ANALYTICAL PROCEDURE FORMETHYLMERCURY

GabrielGiancaspro

AGAR PF 33(4) Pg. 702Chemical Info, Definition, Botanic characteristics, Packagingand storage, USP Reference standards <11>, Identification,Microbial limits <61>, Limit of foreign insoluble matter

Hong Wang

MEDICAL AIR PF 35(4) Pg. 828

IDENTIFICATION/Introduction, ASSAY/Procedure,IMPURITIES/Inorganic Impurities/Carbon Dioxide,IMPURITIES/Inorganic Impurities/Sample,IMPURITIES/Inorganic Impurities/Analysis,IMPURITIES/Inorganic Impurities/Acceptance criteria,IMPURITIES/Inorganic Impurities/Carbon Monoxide,IMPURITIES/Inorganic Impurities/Sulfur Dioxide,IMPURITIES/Inorganic Impurities/Limit of Nitric Oxide andNitrogen Dioxide, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/Labeling

RaviRavichandran

ALENDRONATE SODIUMTABLETS PF 36(5) Pg. 1157 PERFORMANCE TESTS/Dissolution <711> Elena

Gonikberg

ALFUZOSINHYDROCHLORIDEEXTENDED-RELEASETABLETS PF 36(4) Pg. 889

Title, DEFINITION/Introduction, IDENTIFICATION/A.Infrared Absorption <197K>, IDENTIFICATION/B.,ASSAY/Procedure, PERFORMANCE TESTS,PERFORMANCE TESTS/Dissolution <711>,PERFORMANCE TESTS/Uniformity of Dosage Units <905>,IMPURITIES/Organic Impurities/Procedure, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPAlfuzosin Hydrochloride RS, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPAlfuzosin System Suitability Mixture RS&mdash;Alfuzosinhydrochloride containing approximately 0.4% of each of thefollowing impurities: Impurity A: [N-{3-[(4-amino-6,7-dimethoxyquinazolin-2-yl)(methyl)amino]propyl}furan-2-carboxamide](C19H23N5O4385.42) Impurity D: [N-(4-amino-6,7-dimethoxyquinazolin-2-yl)-N-methylpropane-1,3-diamine](C14H21N5O2291.35)

DomenickVicchio

ALPRAZOLAM ORALLY-DISINTEGRATING TABLETSPF 36(4) Pg. 890

Title, DEFINITION/Introduction,IDENTIFICATION/Introduction, ASSAY/Procedure,PERFORMANCE TESTS/Disintegration <701>,PERFORMANCE TESTS/Dissolution <711>,PERFORMANCE TESTS/Uniformity of Dosage Units <905>,IMPURITIES/Organic Impurities/Procedure, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPAlprazolam RS

RaviRavichandran

IMPURITIES/Organic Impurities, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USP

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AMOXICILLIN CAPSULES PF36(4) Pg. 892

Amoxicillin Related Compound C RS [(4S)-2-[5-(4-hydroxyphenyl)-3,6-dioxopiperazin-2-yl]-5,5-dimethylthiazolidine-4-carboxylic acid; amoxicillinrearrangement product](C16H19N3O5S365.40),ADDITIONAL REQUIREMENTS/USP Reference Standards<11>/USP Amoxicillin Related Compound D RS [(4S)-2-{[(R)-2-amino-2-(4-hydroxyphenyl)acetamido](carboxy)methyl}-5,5-dimethylthiazolidine-4-carboxylic acid; amoxicillin openring](C16H21N3O6S383.42), ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPAmoxicillin Related Compound G RS [(2S,5R,6R)-6-{(R)-2-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido]-2-(4-hydroxyphenyl) acetamido}-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; d-hydroxyphenylglycylamoxicillin](C24H26N4O7S514.55)

Ahalya Wise

AMOXICILLIN FOR ORALSUSPENSION PF 36(4) Pg. 894

IMPURITIES/Organic Impurities, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPAmoxicillin Related Compound E RS [(4S)-2-{[(R)-2-amino-2-(4-hydroxyphenyl)acetamido]methyl}-5,5-dimethylthiazolidine-4-carboxylic acid; amoxicillin penilloicderivatives](C15H21N3O4S339.41), ADDITIONALREQUIREMENTS/USP Reference Standards <11>/ USPAmoxicillin Related Compound G RS (2S,5R,6R)-6-{(R)-2-[[(R)-2-amino-2-(4-hydroxyphenyl)acetamido]-2-(4-hydroxyphenyl)acetamido}-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; d-hydroxyphenylglycylamoxicillin](C24H26N4O7S514.55)

Ahalya Wise

AMOXICILLIN TABLETS PF36(4) Pg. 896

IMPURITIES/Organic Impurities, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPAmoxicillin Related Compound A RS [(2S,5R,6R)-6-amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; 6-aminopenicillanicacid](C8H12N2O3S216.26), ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPAmoxicillin Related Compound D RS [(4S)-2-{[(R)-2-amino-2-(4-hydroxyphenyl)acetamido](carboxy)methyl}-5,5-dimethylthiazolidine-4-carboxylic acid; amoxicillin openring](C16H21N3O6S383.42)

Ahalya Wise

AMOXICILLIN ANDCLAVULANATE POTASSIUMFOR ORAL SUSPENSION PF36(4) Pg. 899

IMPURITIES/Organic Impurities, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPAmoxicillin Related Compound A RS [(2S,5R,6R)-6-amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; 6-aminopenicillanicacid](C8H12N2O3S216.26), ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPAmoxicillin Related Compound D RS [(4S)-2-{[(R)-2-amino-2-(4-hydroxyphenyl)acetamido](carboxy)methyl}-5,5-dimethylthiazolidine-4-carboxylic acid; amoxicillin openring](C16H21N3O6S383.42)

Ahalya Wise

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AMOXICILLIN ANDCLAVULANATE POTASSIUMTABLETS PF 36(4) Pg. 901

IMPURITIES/Organic Impurities, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPAmoxicillin Related Compound A RS [(2S,5R,6R)-6-amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; 6-aminopenicillanicacid](C8H12N2O3S216.26), ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPAmoxicillin Related Compound D RS [(4S)-2-{[(R)-2-amino-2-(4-hydroxyphenyl)acetamido](carboxy)methyl}-5,5-dimethylthiazolidine-4-carboxylic acid; amoxicillin openring](C16H21N3O6S383.42)

Ahalya Wise

ANAGRELIDEHYDROCHLORIDE PF 36(5)Pg. 1160

Title, Chemical Info/Chemical Structure, ChemicalInfo/C10H7Cl2N3O&middot;HCl&middot;H2O, ChemicalInfo/310.56, Chemical Info/Anhydrous, Chemical Info/292.55,Chemical Info/CAS, Chemical Info/Imidazo[2,1-b]quinazolin-2(3H)-one, 6,7-dichloro-1,5-dihydro-, monohydrochloride,monohydrate;, Chemical Info/6,7-Dichloro-1,5-dihydroimidazo[2,1-b]-quinazolin-2(3H)-onemonohydrochloride, monohydrate, DEFINITION/Introduction,IDENTIFICATION/A. Infrared Absorption <197K>,IDENTIFICATION/B., IDENTIFICATION/C. IdentificationTests&mdash;General, Chloride <191>, ASSAY/Procedure,IMPURITIES/Inorganic Impurities/Residue on Ignition <281>,IMPURITIES/Inorganic Impurities/Heavy Metals, Method II<231>, IMPURITIES/Organic Impurities/Procedure,SPECIFIC TESTS/Water Determination, Method I <921>,ADDITIONAL REQUIREMENTS/Packaging and Storage,ADDITIONAL REQUIREMENTS/USP Reference Standards<11>/USP Anagrelide Hydrochloride RS, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPAnagrelide Related Compound A RS [ethyl 2-(6-amino-2,3-dichlorobenzylamino)acetate] (C11H14Cl2N2O2277.15),ADDITIONAL REQUIREMENTS/USP Reference Standards<11>/USP Anagrelide Related Compound B RS [(2-amino-5,6-dichloroquinazolin-3(4H)-yl)acetic acid](C10H9Cl2N3O2274.10)

SujathaRamakrishna

ANAGRELIDE CAPSULES PF36(5) Pg. 1162

Title, DEFINITION/Introduction,IDENTIFICATION/Introduction, ASSAY/Procedure,PERFORMANCE TESTS/Dissolution <711>,PERFORMANCE TESTS/Uniformity of Dosage Units <905>,IMPURITIES/Organic Impurities/Procedure, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPAnagrelide Hydrochloride RS, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPAnagrelide Related Compound A RS, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPAnagrelide Related Compound C RS

SujathaRamakrishna

Title, Chemical Info/Chemical Structure, ChemicalInfo/C16H26O5, Chemical Info/298.37, ChemicalInfo/(3R,5aS,6R,8aS,9R,10S,12R,12aR)-Decahydro-10-

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ARTEMETHER PF 36(2) Pg.377

methoxy-3,6,9-trimethyl-3,12-epoxy-12H-pyrano[4.3-j]-1,2-benzodioxepin, ChemicalInfo/CAS, DEFINITION/Introduction, IDENTIFICATION/A.Infrared Absorption <197K>, IDENTIFICATION/B.,ASSAY/Procedure, IMPURITIES/Inorganic Impurities/Residueon Ignition <281>, IMPURITIES/Inorganic Impurities/HeavyMetals, Method II <231>, IMPURITIES/OrganicImpurities/Procedure 1: Analysis of Cyclohexanone PropanalDerivative and Furoisochromen Derivative by TLC,IMPURITIES/Organic Impurities/Procedure 2: Analysis ofArtemether Related Compound A, Artemether RelatedCompound B, and Any Other Individual Impurity by HPLC,SPECIFIC TESTS/Optical Rotation, Specific Rotation <781S>,SPECIFIC TESTS/Color of solution, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPArtemether RS, ADDITIONAL REQUIREMENTS/USPReference Standards <11>/USP Artemether Related CompoundA RS [(3R,5aS,6R,8aS,9R,12R,12aR)-Decahydro-10-hydroxy-3,6,9-trimethyl-3,12-epoxy-12H-pyrano[4,3-j]-1,2-benzodioxepin](C15H24O5284.35),ADDITIONAL REQUIREMENTS/USP Reference Standards<11>/USP Artemether Related Compound B RS[(3R,5aS,6R,8aS,9R,10R,12R,12aR)-Decahydro-10-methoxy-3,6,9-trimethyl-3,12-epoxy-12H-pyrano[4,3-j]-1,2-benzodioxepin](C16H26O5298.37)

BehnamDavani

ARTEMETHER ANDLUMEFANTRINE TABLETSPF 36(2) Pg. 379

Title, DEFINITION/Introduction, IDENTIFICATION/A. ThinLayer Chromatography, IDENTIFICATION/B.,ASSAY/Procedure, PERFORMANCE TESTS,PERFORMANCE TESTS/Dissolution <711>,PERFORMANCE TESTS/Uniformity of Dosage Units <905>,IMPURITIES/Organic Impurities/Procedure 1: Impurities ofArtemether, IMPURITIES/Organic Impurities/Procedure 2:Impurities of Lumefantrine, IMPURITIES/OrganicImpurities/Acceptance criteria, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPArtemether RS, ADDITIONAL REQUIREMENTS/USPReference Standards <11>/USP Artemether Related CompoundA RS [(3R,5aS,6R,8aS,9R,12R,12aR)-Decahydro-10-hydroxy-3,6,9-trimethyl-3,12-epoxy-12H-pyrano[4,3-j]-1,2-benzodioxepin](C15H24O5284.35),ADDITIONAL REQUIREMENTS/USP Reference Standards<11>/USP Artemether Related Compound B RS[(3R,5aS,6R,8aS,9R,10R,12R,12aR)-Decahydro-10-methoxy-3,6,9-trimethyl-3,12-epoxy-12H-pyrano[4,3-j]-1,2-benzodioxepin](C16H26O5298.37), ADDITIONAL

BehnamDavani

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REQUIREMENTS/USP Reference Standards <11>/USPLumefantrine RS, ADDITIONAL REQUIREMENTS/USPReference Standards <11>/USP Lumefantrine RelatedCompound A RS [(RS, Z)-2-(Dibutylamino)-2-(2,7-dichloro-9-(4-chlorobenzylidene)-9H-fluoren-4-yl)ethanol](C30H32Cl3NO528.94)

BETADEX SULFOBUTYLETHER SODIUM PF 36(2) Pg.447

Title, Chemical Info/Chemical Structure, ChemicalInfo/C42H70-nO35&middot;(C4H8SO3Na)n, ChemicalInfo/2163 when n = 6.5, Chemical Info/Beta CyclodextrinSulfobutyl Ethers, Sodium Salts;, Chemical Info/BetaCyclodextrin Sulfobutyl Ether Sodium, Chemical Info/CAS,DEFINITION/Introduction, IDENTIFICATION/A. InfraredAbsorption <197K>, IDENTIFICATION/B.,IDENTIFICATION/C., IDENTIFICATION/D. IdentificationTests&mdash;General, Sodium <191>, ASSAY/Procedure,IMPURITIES/Inorganic Impurities/Heavy Metals, Method II<231>, IMPURITIES/Inorganic Impurities/Limit of SodiumChloride, IMPURITIES/Organic Impurities/Procedure 1: Limitof Beta Cyclodextrin (Betadex), IMPURITIES/OrganicImpurities/Procedure 2: Limit of 4-Hydroxybutane-1-SulfonicAcid, IMPURITIES/Organic Impurities/Procedure 3: Limit ofBis(4-Sulfobutyl) Ether Disodium, IMPURITIES/OrganicImpurities/Procedure 4: Limit of 1,4-Butane Sultone,SPECIFIC TESTS, SPECIFIC TESTS/Bacterial EndotoxinsTest <85>, SPECIFIC TESTS/Microbial Enumeration Tests<61> and Tests for Specified Microorganisms <62>,SPECIFIC TESTS/Clarity of Solution, SPECIFICTESTS/Average Degree of Substitution, SPECIFIC TESTS/pH<791>, SPECIFIC TESTS/Water Determination, Method I<921>, ADDITIONAL REQUIREMENTS/Packaging andStorage, ADDITIONAL REQUIREMENTS/Labeling,ADDITIONAL REQUIREMENTS/USP Reference Standards<11>/USP Beta Cyclodextrin RS, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPBetadex Sulfobutyl Ether Sodium RS, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPEndotoxin RS, ADDITIONAL REQUIREMENTS/USPReference Standards <11>/USP Sodium Chloride RS

Hong Wang

BUTYL STEARATE PF 35(6)Pg. 1502

Title, Chemical Info/Chemical Structure, Chemical Info/ButylOctadecanoate, Chemical Info/C22H44O2, ChemicalInfo/340.59, Chemical Info/CAS, DEFINITION/Introduction,IDENTIFICATION/Infrared Absorption <197F>, SPECIFICTESTS/Solubility in alcohol, SPECIFIC TESTS/SpecificGravity <841>, SPECIFIC TESTS/Fats and Fixed Oils, IodineValue <401>, SPECIFIC TESTS/Melting Range orTemperature, Class III <741>, SPECIFIC TESTS/Fats andFixed Oils, Saponification Value <401>, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/Labeling, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USP ButylStearate RS

Robert Lafaver

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CALCITONIN SALMON PF36(5) Pg. 1174

DEFINITION/Introduction, IMPURITIES/OrganicImpurities/Procedure: Related Peptides and Other RelatedSubstances, SPECIFIC TESTS/Bioidentity, SPECIFICTESTS/Microbial Enumeration Tests <61> and Tests forSpecified Microorganisms <62>

ThomasSigambris

CARBIDOPA ANDLEVODOPA EXTENDED-RELEASE TABLETS PF 34(6)Pg. 1433

Title, Definition, Packaging and storage, Labeling, USPReference standards <11>, Identification, Dissolution <711> -Test 1, Dissolution <711> - Test 2, Dissolution <711> - Test 3,Uniformity of dosage units <905>, Related compounds, Assay

RaviRavichandran

CEFEPIMEHYDROCHLORIDE PF 36(1)Pg. 76

ASSAY/Procedure, IMPURITIES/OrganicImpurities/Procedure 1: Limit of N-Methylpyrrolidine,IMPURITIES/Organic Impurities/Procedure 2: Other OrganicImpurities, ADDITIONAL REQUIREMENTS/USP ReferenceStandards <11>/USP Cefepime Hydrochloride SystemSuitability RS

Ahalya Wise

CEFEPIME FOR INJECTIONPF 36(1) Pg. 79

ASSAY/Procedure, IMPURITIES/OrganicImpurities/Procedure 1: Limit of N-Methylpyrrolidine,IMPURITIES/Organic Impurities/Procedure 2: Other OrganicImpurities, ADDITIONAL REQUIREMENTS/USP ReferenceStandards <11>/USP Cefepime Hydrochloride SystemSuitability RS

Ahalya Wise

CETIRIZINEHYDROCHLORIDE TABLETSPF 36(2) Pg. 389

Title, DEFINITION/Introduction,IDENTIFICATION/Introduction, ASSAY/Procedure,PERFORMANCE TESTS, PERFORMANCETESTS/Dissolution <711>, PERFORMANCETESTS/Uniformity of Dosage Units <905>,IMPURITIES/Organic Impurities/Procedure, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPCetirizine Hydrochloride RS

DomenickVicchio

DESCRIPTION ANDSOLUBILITY PF 36(2) Pg. 578

Artemether, Butyl Stearate, Betadex Sulfobutyl Ether Sodium,Montelukast Sodium, Fosfomycin Tromethamine,Valganciclovir Hydrochloride, Diethyl Sebacate, Lumefantrine,Milbemycin Oxime, Anagrelide Hydrochloride, PolyglycerylDioleate, Hydrogenated Starch Hydrolysate, Albumin Human

BehnamDavani

DIETHYL SEBACATE PF 35(5)Pg. 1203

Title, Chemical Info/Chemical Structure, ChemicalInfo/CH3CH2OOC(CH2)8COOCH2CH3, ChemicalInfo/C14H26O4, Chemical Info/258.35, ChemicalInfo/Decanedioic acid, 1,10-diethyl ester;, ChemicalInfo/Diethyl 1,10-decanedioate, Chemical Info/CAS,DEFINITION/Introduction, IDENTIFICATION/A. InfraredAbsorption <197F>, IDENTIFICATION/B.,ASSAY/Procedure, IMPURITIES/Inorganic Impurities/Residueon Ignition <281>, IMPURITIES/Inorganic Impurities/HeavyMetals, Method II <231>, SPECIFIC TESTS/Specific Gravity<841>, SPECIFIC TESTS/Refractive Index <831>, SPECIFICTESTS/Fats and Fixed Oils, Acid Value <401>, SPECIFICTESTS/Fats and Fixed Oils, Iodine Value <401>,ADDITIONAL REQUIREMENTS/Packaging and Storage,ADDITIONAL REQUIREMENTS/USP Reference Standards

Robert Lafaver

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<11>

DROSPIRENONE ANDETHINYL ESTRADIOLTABLETS PF 36(4) Pg. 914

Title, DEFINITION/Introduction,IDENTIFICATION/Introduction, ASSAY/Procedure,PERFORMANCE TESTS, PERFORMANCETESTS/Dissolution <711>, PERFORMANCETESTS/Uniformity of Dosage Units <905>,IMPURITIES/Organic Impurities/Procedure, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPDrospirenone RS, ADDITIONAL REQUIREMENTS/USPReference Standards <11>/USP Ethinyl Estradiol RS,ADDITIONAL REQUIREMENTS/USP Reference Standards<11>/USP Ethinyl Estradiol Related Compound B RS 19-Nor-17&alpha;-pregna-1,3,5(10),9(11)-tetraen-20-yne-3,17-diol(C20H22O2294.39)

DomenickVicchio

ESTRADIOL TRANSDERMALSYSTEM PF 35(5) Pg. 1136 PERFORMANCE TESTS/Drug Release <724> Margareth

Marques

FENTANYL TRANSDERMALSYSTEM PF 36(2) Pg. 397

Title, DEFINITION/Introduction, IDENTIFICATION/A.,IDENTIFICATION/B. Thin-Layer ChromatographyIdentification Test <201>, ASSAY/Procedure,PERFORMANCE TESTS, PERFORMANCE TESTS/DrugRelease <724>, PERFORMANCE TESTS/Uniformity ofDosage Units <905>, IMPURITIES/Organic Impurities/Procedure 1, IMPURITIES/Organic Impurities /Procedure 2,SPECIFIC TESTS/Alcohol Content, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/Labeling, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPFentanyl Citrate RS, ADDITIONAL REQUIREMENTS/USPReference Standards <11>/ USP Fentanyl Related CompoundE RS 1-phenethyl-N-phenylpiperidine-4-amineC19H24N2&middot; 2HCl353.33, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/ USPFentanyl Related Compound G RS N-(1-phenethyl-4-piperidyl)-acetanilide, acetyl fentanylC21H26N2O322.44,ADDITIONAL REQUIREMENTS/USP Reference Standards<11>/USP Alcohol RS

ClydewynAnthony

Title, Chemical Info/Chemical Structure, ChemicalInfo/C845H1339N223O243S9, Chemical Info/ 18,800 daltons,Chemical Info/CAS, DEFINITION/Introduction,IDENTIFICATION/A, IDENTIFICATION/B,IDENTIFICATION/C: Peptide Mapping, ASSAY/Potency,IMPURITIES/Organic Impurities, IMPURITIES/Procedure1/Solution A, IMPURITIES/Procedure 1/Solution B,IMPURITIES/Procedure 1/Mobile phase,IMPURITIES/Procedure 1/Standard solution,IMPURITIES/Procedure 1/Sample solution,IMPURITIES/Procedure 1/Chromatographic system,IMPURITIES/Procedure 1/System suitability,IMPURITIES/Procedure 1/Analysis, IMPURITIES/Procedure1/Acceptance criteria, IMPURITIES/Procedure 2: Impurities

file:///C|/DOCUME~1/REG/LOCALS~1/Temp/XPgrpwise/compendialDeferrals.html[8/3/2011 2:56:12 PM]

FILGRASTIM PF 36(5) Pg. 1180

With Charges Different From Filgrastim/1 M phosphoric acidsolution, IMPURITIES/Procedure 2: Impurities With ChargesDifferent From Filgrastim/1 M sodium hydroxide solution,IMPURITIES/Procedure 2: Impurities With Charges DifferentFrom Filgrastim/Anolyte solution, IMPURITIES/Procedure 2:Impurities With Charges Different From Filgrastim/Catholytesolution, IMPURITIES/Procedure 2: Impurities With ChargesDifferent From Filgrastim/Initiator, IMPURITIES/Procedure 2:Impurities With Charges Different From Filgrastim/Fixingsolution, IMPURITIES/Procedure 2: Impurities With ChargesDifferent From Filgrastim/Gel wash I, IMPURITIES/Procedure2: Impurities With Charges Different FromFilgrastim/Coomassie staining solution,IMPURITIES/Procedure 2: Impurities With Charges DifferentFrom Filgrastim/Coomassie destaining solution,IMPURITIES/Procedure 2: Impurities With Charges DifferentFrom Filgrastim/Reference solution A,IMPURITIES/Procedure 2: Impurities With Charges DifferentFrom Filgrastim/Reference solution B,IMPURITIES/Procedure 2: Impurities With Charges DifferentFrom Filgrastim/Reference solution C,IMPURITIES/Procedure 2: Impurities With Charges DifferentFrom Filgrastim/Reference solution D,IMPURITIES/Procedure 2: Impurities With Charges DifferentFrom Filgrastim/Sample solution, IMPURITIES/Procedure 2:Impurities With Charges Different From Filgrastim/Analysis,IMPURITIES/Procedure 3: Impurities With Molecular WeightDifferent From That of Filgrastim/4X SDS sample buffer(nonreducing conditions), IMPURITIES/Procedure 3:Impurities With Molecular Weight Different From That ofFilgrastim/4X SDS sample buffer (reducing conditions),IMPURITIES/Procedure 3: Impurities With Molecular WeightDifferent From That of Filgrastim/1X SDS sample buffer(nonreducing conditions), IMPURITIES/Procedure 3:Impurities With Molecular Weight Different From That ofFilgrastim/1X SDS sample buffer (reducing conditions),IMPURITIES/Procedure 3: Impurities With Molecular WeightDifferent From That of Filgrastim/Gel wash I,IMPURITIES/Procedure 3: Impurities With Molecular WeightDifferent From That of Filgrastim/Gel wash II,IMPURITIES/Procedure 3: Impurities With Molecular WeightDifferent From That of Filgrastim/Reducer solution,IMPURITIES/Procedure 3: Impurities With Molecular WeightDifferent From That of Filgrastim/Silver nitrate solution,IMPURITIES/Procedure 3: Impurities With Molecular WeightDifferent From That of Filgrastim/Developer,IMPURITIES/Procedure 3: Impurities With Molecular WeightDifferent From That of Filgrastim/Acetic acid solution,IMPURITIES/Procedure 3: Impurities With Molecular WeightDifferent From That of Filgrastim/Running buffer,IMPURITIES/Procedure 3: Impurities With Molecular WeightDifferent From That of Filgrastim/Resolving gel,IMPURITIES/Procedure 3: Impurities With Molecular WeightDifferent From That of Filgrastim/Reference solution A,

ClydewynAnthony

file:///C|/DOCUME~1/REG/LOCALS~1/Temp/XPgrpwise/compendialDeferrals.html[8/3/2011 2:56:12 PM]

IMPURITIES/Procedure 3: Impurities With Molecular WeightDifferent From That of Filgrastim/Reference solution B,IMPURITIES/Procedure 3: Impurities With Molecular WeightDifferent From That of Filgrastim/Reference solution C,IMPURITIES/Procedure 3: Impurities With Molecular WeightDifferent From That of Filgrastim/Reference solution D,IMPURITIES/Procedure 3: Impurities With Molecular WeightDifferent From That of Filgrastim/Sample solution,IMPURITIES/Procedure 3: Impurities With Molecular WeightDifferent From That of Filgrastim/Analysis,IMPURITIES/Procedure 4: Limit of High Molecular WeightProteins/Mobile phase, IMPURITIES/Procedure 4: Limit ofHigh Molecular Weight Proteins/Column conditioning solution,IMPURITIES/Procedure 4: Limit of High Molecular WeightProteins/Resolution solution, IMPURITIES/Procedure 4: Limitof High Molecular Weight Proteins/Standard solution,IMPURITIES/Procedure 4: Limit of High Molecular WeightProteins/Sample solution, IMPURITIES/Procedure 4: Limit ofHigh Molecular Weight Proteins/Chromatographic system,IMPURITIES/Procedure 4: Limit of High Molecular WeightProteins/System suitability, IMPURITIES/Procedure 4: Limitof High Molecular Weight Proteins/Analysis,IMPURITIES/Procedure 4: Limit of High Molecular WeightProteins/Acceptance criteria, SPECIFIC TESTS/ProteinConcentration, SPECIFIC TESTS/Microbial Enumeration Tests<61>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>,ADDITIONAL REQUIREMENTS/Packaging and Storage,ADDITIONAL REQUIREMENTS/Labeling, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPEndotoxin RS, ADDITIONAL REQUIREMENTS/USPReference Standards <11>/USP Filgrastim RS

FOSFOMYCINTROMETHAMINE PF 36(2) Pg.404

Title, Chemical Info/Chemical Structure, ChemicalInfo/C3H7O4P&middot;C4H11NO3, Chemical Info/259.19,Chemical Info/Phosphonic acid, (3-methyloxiranyl)-, (2R-cis)-, compd. with 2-amino-2-(hydroxymethyl)-1,3-propanediol(1:1);, Chemical Info/(1R,2S)-(1,2-Epoxypropyl)phosphonicacid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), Chemical Info/CAS,DEFINITION/Introduction, IDENTIFICATION/A. InfraredAbsorption <197K>, IDENTIFICATION/B.,IDENTIFICATION/C., ASSAY/Procedure,IMPURITIES/Inorganic Impurities/Heavy Metals, Method I<231>, IMPURITIES/Inorganic Impurities/Limit of InorganicPhosphates, IMPURITIES/Organic Impurities/Procedure,SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/OpticalRotation, Specific Rotation <781S>, SPECIFIC TESTS/WaterDetermination, Method Ic <921>, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPFosfomycin Tromethamine RS

BehnamDavani

Chemical Info/Molecular Weight, Chemical Info/ChemicalName, DEFINITION/Introduction,

file:///C|/DOCUME~1/REG/LOCALS~1/Temp/XPgrpwise/compendialDeferrals.html[8/3/2011 2:56:12 PM]

GLUCAGON PF 35(5) Pg. 1148

IDENTIFICATION/Introduction, IDENTIFICATION/A,IDENTIFICATION/B, ASSAY/Procedure, OTHERCOMPONENTS/Nitrogen Determination, Method II <461>,IMPURITIES/Inorganic Impurities, IMPURITIES/OrganicImpurities/Procedure, SPECIFIC TESTS/Water Determination,Method IMethod Ic <921>, SPECIFIC TESTS/BacterialEndotoxins Test <85>, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/USP Reference Standards <11>

ThomasSigambris

GLUCAGON FOR INJECTIONPF 35(5) Pg. 1152

DEFINITION/Introduction, IDENTIFICATION/Introduction,ASSAY/Procedure, IMPURITIES/Organic Impurities,SPECIFIC TESTS/Water Determination, Method Ic <921>,SPECIFIC TESTS/pH and Clarity of solution, SPECIFICTESTS/Bacterial Endotoxins Test <85>, SPECIFICTESTS/Sterility Tests <71>, SPECIFIC TESTS/OtherRequirements, ADDITIONAL REQUIREMENTS/Labeling,ADDITIONAL REQUIREMENTS/USP Reference Standards<11>

ThomasSigambris

HELIUM PF 35(4) Pg. 850

IDENTIFICATION/A., IDENTIFICATION/B.,IDENTIFICATION/Introduction, ASSAY/Procedure,IMPURITIES/Inorganic Impurities/Carbon Monoxide,IMPURITIES/Inorganic Impurities/Acceptance criteria,SPECIFIC TESTS/Odor, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/Labeling

RaviRavichandran

HEPARIN CALCIUM PF 36(5)Pg. 1185

Title, DEFINITION/Introduction, IDENTIFICATION,IDENTIFICATION/A. 1H NMR Spectrum,IDENTIFICATION/B. Identification Tests&mdash;General,Calcium <191>, ASSAY/Anti-Factor IIa Potency

Anita Szajek

HYDROMORPHONEHYDROCHLORIDE PF 35(5)Pg. 1156

IMPURITIES/Organic Impurities/Procedure, ADDITIONALREQUIREMENTS/ USP Reference Standards <11>

ClydewynAnthony

HYDROXYPROPYL CORNSTARCH PF 36(5) Pg. 1229 Title Hong Wang

LORATADINE ORALLY-DISINTEGRATING TABLETSPF 34(3) Pg. 624

Title, Definition, Packaging and storage, USP Referencestandards <11>, Identification, Disintegration <701>,Dissolution <711>, Uniformity of dosage units <905>, Relatedcompounds, Assay

Mary Waddell

LORATADINE ANDPSEUDOEPHEDRINESULFATE EXTENDED-RELEASE TABLETS PF 32(6)Pg. 1715

Title, Definition, Packaging and storage, USP Referencestandards <11>, Identification, Dissolution <711>, Uniformityof dosage units <905>, Loss on drying <731>, Loratadinechromatographic purity, Pseudoephedrine sulfatechromatographic purity, Assay for loratadine, Assay forpseudoephedrine sulfate

Mary Waddell

Title, Chemical Info/Chemical Structure, ChemicalInfo/C30H32Cl3NO, Chemical Info/528.94, ChemicalInfo/(&plusmn;)-2,7-Dichloro-9-[(Z)-p-chlorobenzylidine]-&alpha;

file:///C|/DOCUME~1/REG/LOCALS~1/Temp/XPgrpwise/compendialDeferrals.html[8/3/2011 2:56:12 PM]

LUMEFANTRINE PF 36(2) Pg.413

[(dibutylamino)methyl]-fluorene-4-methanol, ChemicalInfo/CAS, DEFINITION/Paragraph Text,IDENTIFICATION/A. Infrared Absorption <197K>,IDENTIFICATION/B., ASSAY/Procedure,IMPURITIES/Inorganic Impurities/Residue on Ignition <281>,IMPURITIES/Inorganic Impurities/Heavy Metals, Method II<231>, IMPURITIES/Organic Impurities/Procedure,ADDITIONAL REQUIREMENTS/Packaging and Storage,ADDITIONAL REQUIREMENTS/USP Reference Standards<11>/USP Lumefantrine RS, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPLumefantrine Related Compound A RS [(RS, Z)-2-(Dibutylamino)-2-(2,7-dichloro-9-(4-chlorobenzylidene)-9H-fluoren-4-yl)ethanol](C30H32Cl3NO528.94),ADDITIONAL REQUIREMENTS/USP Reference Standards<11>/USP Lumefantrine Related Compound B RSLumefantrine related compound B is a mixture of isomers Aand B. [Isomer A is (1S,3R,5R)-1,3-bis[(EZ)-2,7-Dichloro-9-(4-chlorobenzylidene)-9H-fluoren-4-yl]-2,6-dioxabicyclo[3.1.0]hexane.] [Isomer Bis 2-((EZ)-2,7-Dichloro-9-(4-chlorobenzylidene)-9H-fluoren-4-yl)-3'-((EZ)-2,7-dichloro-9-(4-chlorobenzylidene)-9H-fluoren-4-yl)-2,2'-bioxirane.](C44H24Cl6O2797.4)

BehnamDavani

METOLAZONE TABLETS PF35(6) Pg. 1464 PERFORMANCE TESTS/Dissolution Margareth

Marques

Title, Chemical Info/Chemical Structure, ChemicalInfo/C31H43NO7 (Milbemycin A3 Oxime), ChemicalInfo/541.68, Chemical Info/Milbemycin B, 5-O-demethyl-28-deoxy-25-methyl-6,28-epoxy-23-hydroxyimino-,[6R,23S,25S(E)]-;, ChemicalInfo/(2&alpha;E,4E,5&prime;S,6R,6&prime;S,8E,11R,13R,15S,17&alpha;R,20&alpha;R,20&beta;S)-6&prime;-ethyl-3&prime;,4&prime;,5&prime;,6,6&prime;,7,10,11,14,15,17&alpha;,20,20&alpha;,20&beta;-tetradecahydro-20&beta;-hydroxy-5&prime;,6,8,19-tetramethylspiro[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2&prime;-[2H]pyran]-17-one 20-oxime;, Chemical Info/(1R, 4S, 5&prime;S, 6R, 6&prime;R, 8R, 13R, 20R, 24S, 10E, 14E, 16E, 22Z)-24-hydroxy-21-hydroxyimino-2-oxo-11, 13, 22-trimethyl-3, 7, 19-trioxatetracyclo-[15, 6, 1,14,8,020,24] pentacosa-10, 14, 16, 22-tetraene-6-spiro-2&prime;-(5,&prime;6&prime;-dimethyltetrahydropyran), Chemical Info/C32H45NO7(Milbemycin A4 Oxime),Chemical Info/555.70, Chemical Info/Milbemycin B, 5-O-demethyl-28-deoxy-25-ethyl-6,28-epoxy-23-hydroxyimino-,

file:///C|/DOCUME~1/REG/LOCALS~1/Temp/XPgrpwise/compendialDeferrals.html[8/3/2011 2:56:12 PM]

MILBEMYCIN OXIME PF36(2) Pg. 417

[6R,23S,25S(E)]-;, ChemicalInfo/(2&alpha;E,4E,5&prime;S,6R,6&prime;S,8E,11R,13R,15S,17&alpha;R,20&alpha;R,20&beta;S)-6&prime;-3&prime;,4&prime;,5&prime;,6,6&prime;,7,10,11,14,15,17&alpha;,20,20&alpha;,20&beta;-tetradecahydro-20&beta;-hydroxy-5&prime;,6&prime;,6,8,19-pentamethylspiro[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2&prime;-[2H]pyran]-17-one20-oxime;, Chemical Info/(1R, 4S, 5&prime;S, 6R, 6&prime;R, 8R, 13R, 20R, 24S, 10E, 14E, 16E, 22Z)-24-hydroxy-21-hydroxyimino-2-oxo-11, 13, 22-trimethyl-3, 7, 19-trioxatetracyclo-[15, 6, 1,14,8,020,24] pentacosa-10, 14, 16, 22-tetraene-6-spiro-2&prime;-(6&prime;-ethyl-5&prime;-methyltetrahydropyran);, ChemicalInfo/Mixture of milbemycin A3oxime and milbemycin A4 oxime, Chemical Info/CAS,DEFINITION/Introduction,IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure,IMPURITIES/Organic Impurities/Procedure, SPECIFIC TESTS/Water Determination,Method I <921>,ADDITIONAL REQUIREMENTS/Packaging and Storage,ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Milbemycin Oxime RS

MorganPuderbaugh

MONTELUKAST SODIUM PF36(1) Pg. 121

Title, Chemical Info/Chemical Structure, ChemicalInfo/C35H35ClNNaO3S, Chemical Info/ 608.17, ChemicalInfo/Cyclopropaneacetic acid, 1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]-, sodium salt, [R-,(E)]-;, ChemicalInfo/Sodium 1-[[[(R)-m-[(E)-2-(7-chloro-2-quinolyl)vinyl]-&alpha;-[o-(1-hydroxy-1-methylethyl)phenethyl]benzyl]thio]-methyl]cyclopropaneacetate, ChemicalInfo/CAS, Chemical Info/C35H36ClNO3S, Chemical Info/586.18, Chemical Info/Montelukast,DEFINITION/Introduction,IDENTIFICATION/A. Infrared Absorption <197>,IDENTIFICATION/B.Identification Tests&#151;General, Sodium <191>, IDENTIFICATION/C., ASSAY/Note, ASSAY/Procedure,IMPURITIES/Inorganic Impurities/Heavy Metals,IMPURITIES/Organic Impurities/Procedure, SPECIFICTESTS/Water Determination, Method Ia <921>, SPECIFICTESTS/Enantiomeric Purity, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards<11>/USP Montelukast

Mary Waddell

file:///C|/DOCUME~1/REG/LOCALS~1/Temp/XPgrpwise/compendialDeferrals.html[8/3/2011 2:56:12 PM]

Sodium RS, ADDITIONAL REQUIREMENTS/USPReference Standards <11>/USPMontelukast Dicyclohexylamine (DCHA) RS, ADDITIONALREQUIREMENTS/USP Reference Standards<11>/(C35H36ClNO3S&middot;C12H23N767.50), ADDITIONAL REQUIREMENTS/USP Reference Standards<11>/USP Montelukast Racemate RS, ADDITIONAL REQUIREMENTS/USPReferenceStandards <11>/USP Montelukast for Peak Identification RS

MORPHINE SULFATE EXTENDED-RELEASECAPSULES PF 36(2) Pg. 422

PERFORMANCE TESTS/Dissolution <711>

ClydewynAnthony

MORPHINE SULFATE EXTENDED-RELEASETABLETS PF 35(5) Pg. 1164

Title, DEFINITION/Introduction,IDENTIFICATION/A. Identification Tests-General, Sulfate<191>,IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCETESTS, PERFORMANCE TESTS/Drug Release <724>, PERFORMANCETESTS/Uniformity of DosageUnits <905>, IMPURITIES/Organic Impurities/Procedure,ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/USP Reference Standards <11>

ClydewynAnthony

NITROGEN PF 35(4) Pg. 910

IDENTIFICATION/Introduction,ASSAY/Procedure, IMPURITIES/Inorganic Impurities/CarbonMonoxide,SPECIFIC TESTS/Odor, ADDITIONALREQUIREMENTS/Packaging and Storage,ADDITIONAL REQUIREMENTS/Labeling

RaviRavichandran

NITROGEN 97 PERCENT PF35(4) Pg. 911

DEFINITION/Introduction, IDENTIFICATION/Introduction,ASSAY/Procedure, IMPURITIES/Inorganic Impurities/CarbonDioxide, IMPURITIES/Inorganic Impurities/Carbon Monoxide,IMPURITIES/Inorganic Impurities/Sulfur Dioxide,IMPURITIES/Inorganic Impurities/Limit of Nitric Oxide andNitrogen Dioxide, ADDITIONALREQUIREMENTS/Packaging and Storage

RaviRavichandran

NITROUS OXIDE PF 35(4) Pg.859

DEFINITION/Introduction, IDENTIFICATION/A.,IDENTIFICATION/B., IDENTIFICATION/C.,ASSAY/Procedure, IMPURITIES/InorganicImpurities/Ammonia, IMPURITIES/Inorganic Impurities/NitricOxide, IMPURITIES/Inorganic Impurities/Nitrogen Dioxide,IMPURITIES/Inorganic Impurities/Halogens,IMPURITIES/Inorganic Impurities/Carbon Monoxide,IMPURITIES/Inorganic Impurities/Carbon Dioxide, SPECIFICTESTS/Water, ADDITIONAL REQUIREMENTS/Packagingand Storage, ADDITIONAL REQUIREMENTS/Labeling

RaviRavichandran

NONYLPARABEN PF 36(2) Pg. Nonylparaben (4-Hydroxybenzoic acid nonyl ester, nonyl 4- Morgan

file:///C|/DOCUME~1/REG/LOCALS~1/Temp/XPgrpwise/compendialDeferrals.html[8/3/2011 2:56:12 PM]

575 hydroxybenzoate), Puderbaugh

OLMESARTAN MEDOXOMILPF 36(5) Pg. 1197

Title, Chemical Info/Chemical Structure, ChemicalInfo/C29H30N6O6, Chemical Info/558.59, Chemical Info/1H-Imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2&prime;-(1H-tetrazol-5-yl) [1,1&prime;-biphenyl]-4-yl]methyl]-, (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl ester, Chemical Info/CAS,DEFINITION/Introduction, IDENTIFICATION/A. InfraredAbsorption <197K>, IDENTIFICATION/B.,ASSAY/Procedure, IMPURITIES/Inorganic Impurities/Residueon Ignition <281>, IMPURITIES/Inorganic Impurities/HeavyMetals, Method II <231>, IMPURITIES/OrganicImpurities/Procedure, SPECIFIC TESTS/Limit of Acetone (ifpresent), SPECIFIC TESTS/Water Determination, Method Ic<921>, ADDITIONAL REQUIREMENTS/Packaging andStorage, ADDITIONAL REQUIREMENTS/USP ReferenceStandards <11>/USP Olmesartan Medoxomil RS,ADDITIONAL REQUIREMENTS/USP Reference Standards<11>/USP Olmesartan Medoxomil Related Compound A RS

SujathaRamakrishna

ORLISTAT PF 35(5) Pg. 1166

Title, Chemical Info/Chemical Structure, ChemicalInfo/C29H53NO5, Chemical Info/495.73, Chemical Info/l-Leucine, N-formyl-, 1-[(3-hexyl-4-oxo-2-oxetanyl)methyl]dodecyl ester, [2S-[2&alpha;(R*), 3&beta;]]-;, Chemical Info/N-Formyl-l-leucine, ester with (3S,4S)-3-hexyl-4-[(2S)-2-hydroxytridecyl]-2-oxetanone, ChemicalInfo/CAS, DEFINITION/Introduction, IDENTIFICATION/A.Infrared Absorption <197M>, IDENTIFICATION/B.,ASSAY/Procedure, IMPURITIES/Inorganic Impurities/Residueon Ignition <281>, IMPURITIES/Inorganic Impurities/HeavyMetals, Method II <231>, IMPURITIES/OrganicImpurities/Procedure 1: Limit of Orlistat Related Compound A,IMPURITIES/Organic Impurities/Procedure 2: Limit ofOrlistat Related Compound B, IMPURITIES/OrganicImpurities/Procedure 3, IMPURITIES/OrganicImpurities/Procedure 4: Limit of Orlistat Related Compound D,IMPURITIES/Organic Impurities/Procedure 5: Limit ofOrlistat Related Compound E, SPECIFIC TESTS/OpticalRotation, Specific Rotation <781>, SPECIFIC TESTS/WaterDetermination, Method Ic <921>, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/USP Reference Standards <11>

ClydewynAnthony

ORLISTAT CAPSULES PF35(5) Pg. 1169

Title, DEFINITION/Introduction,IDENTIFICATION/Introduction, ASSAY/Procedure,PERFORMANCE TESTS, PERFORMANCETESTS/Uniformity of Dosage Units <905>,IMPURITIES/Organic Impurities/Procedure, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/USP Reference Standards <11>

ClydewynAnthony

OXCARBAZEPINE PF 34(5)Pg. 1177 Related compounds Ravi

Ravichandran

file:///C|/DOCUME~1/REG/LOCALS~1/Temp/XPgrpwise/compendialDeferrals.html[8/3/2011 2:56:12 PM]

OXCARBAZEPINE TABLETSPF 34(6) Pg. 1478

Title, Definition, Packaging and storage, USP Referencestandards <11>, Identification, Uniformity of dosage units<905>, Related compounds, Assay

RaviRavichandran

OXYGEN PF 35(4) Pg. 861

IDENTIFICATION/Procedure, IDENTIFICATION/B.Procedure, ASSAY/Procedure, IMPURITIES/InorganicImpurities/Carbon Dioxide, IMPURITIES/InorganicImpurities/Carbon Monoxide, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/Labeling

RaviRavichandran

OXYGEN 93 PERCENT PF35(4) Pg. 862

IDENTIFICATION/A. Procedure, IDENTIFICATION/B.Procedure, ASSAY/Procedure, IMPURITIES/InorganicImpurities/Carbon Dioxide, IMPURITIES/InorganicImpurities/Carbon Monoxide, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/Labeling

RaviRavichandran

PANCURONIUM BROMIDEINJECTION PF 32(4) Pg. 1097

Title, Definition, Packaging and storage, USP Referencestandards <11>, Identification, Bacterial endotoxins <85>, pH<791>, Particulate matter <788>, Related compounds, Otherrequirements, Assay

Mary Waddell

POLYGLYCERYL DIOLEATEPF 36(5) Pg. 1234

Title, ChemicalInfo/R&ndash;O&ndash;(CH2&ndash;CH(OR)&ndash;CH2&ndash;O)3&ndash;R, Chemical Info/R = H, orCO&ndash;C17H33, Chemical Info/1,2,3-Propanetriol,homopolymer, (9Z)-9-octadecenoate,, ChemicalInfo/Polyglyceryl 3 Dioleate, Chemical Info/CAS, ChemicalInfo/R&ndash;O&ndash;(CH2&ndash;CH(OR)&ndash;CH2&ndash;O)6&ndash;R, Chemical Info/Polyglyceryl 6Dioleate, DEFINITION/Introduction, IDENTIFICATION/A.Infrared Absorption <197F>, IDENTIFICATION/B.,IDENTIFICATION/C., ASSAY/Content of Fatty Acids,IMPURITIES/Inorganic Impurities/Residue on Ignition,IMPURITIES/Inorganic Impurities/Heavy Metals, Method II<231>, SPECIFIC TESTS/Acid Value, SPECIFIC TESTS/Fatsand Fixed Oils, Hydroxyl Value <401>, SPECIFICTESTS/Iodine Value, SPECIFIC TESTS/Fats and Fixed Oils,Peroxide Value <401>, SPECIFIC TESTS/Fats and Fixed Oils,Saponification Value <401>, SPECIFIC TESTS/Water,Method I <921>, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/Labeling, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPMethyl Myristate RS, ADDITIONAL REQUIREMENTS/USPReference Standards <11>/USP Methyl Palmitate RS,ADDITIONAL REQUIREMENTS/USP Reference Standards<11>/USP Methyl Palmitoleate RS, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPMethyl Stearate RS, ADDITIONAL REQUIREMENTS/USPReference Standards <11>/USP Methyl Oleate RS,ADDITIONAL REQUIREMENTS/USP Reference Standards<11>/USP Methyl Linoleate RS, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USP

Hong Wang

file:///C|/DOCUME~1/REG/LOCALS~1/Temp/XPgrpwise/compendialDeferrals.html[8/3/2011 2:56:12 PM]

Methyl Linolenate RS, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPPolyglyceryl 3 Dioleate RS, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPPolyglyceryl 6 Dioleate RS

PROMETHAZINE ANDPHENYLEPHRINEHYDROCHLORIDE ORALSOLUTION PF 35(2) Pg. 298

Title, DEFINITION/Introduction,IDENTIFICATION/Introduction, ASSAY/Procedure,IMPURITIES/Organic Impurities/Procedure 1,IMPURITIES/Organic Impurities/Procedure 2, SPECIFICTESTS, SPECIFIC TESTS/ pH <791>, SPECIFIC TESTS/Alcohol Determination (if present), Method II <611>,SPECIFIC TESTS/Deliverable Volume <698>, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/ USP Reference Standards <11>

ClydewynAnthony

PROMETHAZINE ANDPHENYLEPHRINEHYDROCHLORIDE ANDCODEINE PHOSPHATE ORALSOLUTION PF 35(2) Pg. 301

Title, DEFINITION/Introduction,IDENTIFICATION/Introduction, ASSAY/Procedure,IMPURITIES/Organic Impurities/Procedure 1,IMPURITIES/Organic Impurities/Procedure 2, SPECIFICTESTS, SPECIFIC TESTS/pH <791>, SPECIFICTESTS/Alcohol Determination, Method II <611> (if present),SPECIFIC TESTS/Deliverable Volume <698>, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/USP Reference Standards <11>

ClydewynAnthony

PROMETHAZINEHYDROCHLORIDE ANDCODEINE PHOSPHATE ORALSOLUTION PF 35(2) Pg. 292

Title, DEFINITION/Introduction,IDENTIFICATION/Introduction, ASSAY/Procedure,IMPURITIES/Organic Impurities/Procedure 1,IMPURITIES/Organic Impurities/Procedure 2, SPECIFICTESTS, SPECIFIC TESTS/ pH <791>, SPECIFICTESTS/Alcohol Determination (if present), Method II <611>,SPECIFIC TESTS/ Deliverable Volume <698>,ADDITIONAL REQUIREMENTS/Packaging and Storage,ADDITIONAL REQUIREMENTS/ USP Reference Standards<11>

ClydewynAnthony

PROMETHAZINEHYDROCHLORIDE ANDDEXTROMETHORPHANHYDROBROMIDE ORALSOLUTION PF 35(2) Pg. 295

Title, DEFINITION/Introduction,IDENTIFICATION/Introduction, ASSAY/Procedure,IMPURITIES/Organic Impurities/Procedure 1,IMPURITIES/Organic Impurities/Procedure 2, SPECIFICTESTS, SPECIFIC TESTS/ pH <791>, SPECIFICTESTS/Alcohol Determination (if present), Method II <611>,SPECIFIC TESTS/ Deliverable Volume <698>,ADDITIONAL REQUIREMENTS/Packaging and Storage,ADDITIONAL REQUIREMENTS/USP Reference Standards<11>

ClydewynAnthony

RIBAVIRIN CAPSULES PF35(3) Pg. 576

Title, DEFINITION/Introduction,IDENTIFICATION/Introduction, ASSAY/Procedure,PERFORMANCE TESTS/Dissolution <711>,PERFORMANCE TESTS/Uniformity of Dosage Units <905>,IMPURITIES/Organic Impurities/Procedure, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/USP Reference Standards <11>

Leonel Santos

file:///C|/DOCUME~1/REG/LOCALS~1/Temp/XPgrpwise/compendialDeferrals.html[8/3/2011 2:56:12 PM]

ROPINIROLEHYDROCHLORIDE PF 36(1)Pg. 133

IMPURITIES/Organic Impurities /Procedure 1,IMPURITIES/Organic Impurities /Procedure 2, ADDITIONALREQUIREMENTS/Labeling

RaviRavichandran

SCAFFOLD PORCINEDERMIS PF 36(5) Pg. 1209

Title, DEFINITION/Introduction, SPECIFICTESTS/Histological Evaluation, SPECIFICTESTS/Biochemical Analysis, SPECIFIC TESTS/ThermalAnalysis, SPECIFIC TESTS/Biomechanical Analysis,SPECIFIC TESTS/Sterility Tests <71>, ADDITIONALREQUIREMENTS/Labeling, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/USP Authentic Visual References <11>

Fouad Atouf

SCAFFOLD PORCINEDERMIS CROSS-LINKED PF36(5) Pg. 1212

Title, DEFINITION/Introduction, SPECIFICTESTS/Histological Evaluation, SPECIFIC TESTS/MoistureContent, SPECIFIC TESTS/Collagen Content, SPECIFICTESTS/Fat Content, SPECIFIC TESTS/Tensile Strength,SPECIFIC TESTS/Visual Inspection, SPECIFICTESTS/Sterility Tests <71>, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/Labeling, ADDITIONALREQUIREMENTS/USP Visual Reference Standards <11>

Fouad Atouf

SCAFFOLD HUMANPERIPHERAL NERVE PF 36(5)Pg. 1205

Title, DEFINITION/Introduction, SPECIFICTESTS/Histological Evaluation, SPECIFIC TESTS/ChABCaseResidual Testing, SPECIFIC TESTS/Visual, SPECIFICTESTS/Safety, SPECIFIC TESTS/Suture Pullout, SPECIFICTESTS/Sterility Tests <71>, ADDITIONALREQUIREMENTS/Labeling, ADDITIONALREQUIREMENTS/Packaging, Sterilization, and Storage,ADDITIONAL REQUIREMENTS/USP Authentic VisualReferences <11>

Fouad Atouf

SENNOSIDES PF 35(2) Pg. 309SPECIFIC TESTS/Content of Sennosides A and B,ADDITIONAL REQUIREMENTS/USP Reference Standards<11>

Maged Sharaf

SERTRALINEHYDROCHLORIDE PF 34(5)Pg. 1189

Related compounds RaviRavichandran

HYDROGENATED STARCHHYDROLYSATE PF 35(1) Pg.136

Title, Chemical Info, Definition, Packaging and storage,Labeling, USP Reference standards <11>, Identification,Microbial limits <61>, pH <791>, Water, Method I <921>,Residue on ignition <281>, Reducing sugars, Limit of chloride,Limit of sulfate <221>, Limit of nickel, Content of maltitoland sorbitol, Hydrogenated polysaccharides

Hong Wang

SUMATRIPTAN TABLETS PF35(4) Pg. 871 IMPURITIES/Organic Impurities/Procedure Ravi

Ravichandran

Title, Chemical Info/Chemical Structure, ChemicalInfo/C44H69NO12&middot;H2O, Chemical Info/822.03,Chemical Info/15,19-Epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-

file:///C|/DOCUME~1/REG/LOCALS~1/Temp/XPgrpwise/compendialDeferrals.html[8/3/2011 2:56:12 PM]

TACROLIMUS PF 35(2) Pg. 310

tetrone-5,6,8,11,12,13,14,15, 16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-, monohydrate, [3S-[3R*,E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-;, Chemical Info/(&minus;)-(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate, Chemical Info/CAS, DEFINITION/Introduction,IDENTIFICATION/A. Infrared Absorption <197M>,IDENTIFICATION/B., IDENTIFICATION/C.,ASSAY/Procedure, IMPURITIES/Inorganic Impurities/Residueon Ignition <281>, IMPURITIES/Inorganic Impurities/HeavyMetals, Method II <231>, IMPURITIES/OrganicImpurities/Procedure, SPECIFIC TESTS/Optical Rotation,Specific Rotation <781S>, SPECIFIC TESTS/WaterDetermination, Method I <921>, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/USP Reference Standards <11>

Ahalya Wise

TACROLIMUS CAPSULES PF35(2) Pg. 312

Title, DEFINITION/Introduction, IDENTIFICATION/A.Procedure, IDENTIFICATION/B., ASSAY/Procedure,PERFORMANCE TESTS/Uniformity of Dosage Units <905>,IMPURITIES/Organic Impurities/Procedure, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/USP Reference Standards <11>

Ahalya Wise

TOPIRAMATE CAPSULES PF36(4) Pg. 930

DEFINITION/Introduction, IDENTIFICATION/A. InfraredAbsorption <197F>, IDENTIFICATION/B.,ASSAY/Procedure, PERFORMANCE TESTS,PERFORMANCE TESTS/Dissolution <711>,PERFORMANCE TESTS/Uniformity of Dosage Units <905>,IMPURITIES/Organic Impurities/Procedure, SPECIFICTESTS/Limit of Sulfamate and Sulfate, ADDITIONALREQUIREMENTS/Packaging and Storage, ADDITIONALREQUIREMENTS/Labeling, ADDITIONALREQUIREMENTS/USP Reference Standards <11>/USPTopiramate RS, ADDITIONAL REQUIREMENTS/USPReference Standards <11>/USP Topiramate Related CompoundA RS 2,3:4,5-bis-O-(1-methylethylidene)-d-fructopyranose(C12H20O6260.28)

RaviRavichandran

USP AND NF EXCIPIENTS,

{Emollient} Butyl Stearate, {Emulsifying and/or SolubilizingAgent} Polyglyceryl Dioleate, {Flavors and Perfumes} DiethylSebacate, {Humectant} Hydrogenated Starch Hydrolysate,{Sweetening Agent} Hydrogenated Starch Hydrolysate,{Tablet Binder} Hydrogenated Starch Hydrolysate, {Tablet

file:///C|/DOCUME~1/REG/LOCALS~1/Temp/XPgrpwise/compendialDeferrals.html[8/3/2011 2:56:12 PM]

LISTED BY CATEGORY PF35(6) Pg. 1488 and/or Capsule Diluent} Hydrogenated Starch Hydrolysate,

{Complexing Agent} Betadex Sulfobutyl Ether Sodium,{Sequestering Agent} Betadex Sulfobutyl Ether Sodium,{Wetting and/or Solubilizing Agent} Betadex Sulfobutyl EtherSodium

Robert Lafaver

VALGANCICLOVIRHYDROCHLORIDE PF 36(4)Pg. 935

IMPURITIES/Organic Impurities/Procedure 3, SPECIFICTESTS/Enantiomeric Purity of Valganciclovir Leonel Santos